Registration of Mifepristone Linepharma (RU 486) and GyMiso (misoprostol)
Behind the news
This TGA behind-the-news article was published on 30 August 2012. Behind the news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.
The drugs for medical termination of pregnancy, Mifepristone Linepharma (RU 486) and GyMiso® (misoprostol) have been registered today by the Therapeutic Goods Administration (TGA) for wider use in Australia following an application for registration of the medicines by Marie Stopes International Australia.
Mifepristone has been available in Australia since 2006 through the TGA Authorised Prescriber Scheme. With the medicine now included on the Australian Register of Therapeutic Goods (ARTG), medical termination will now be available to a wider group of Australian women.
Under the provisions of the registration, Marie Stopes International Australia is introducing the medicines in a controlled way for the safe use of the medicines, including a tailored educational package which they have developed and will be made available for medical practitioners who wish to prescribe mifepristone.
This will mean that only medical practitioners recognised by Marie Stopes International Australia as having completed appropriate training will be able to prescribe the medicines.
The decision to include Mifepristone on the Australian Register of Therapeutic Goods (ARTG) has followed the TGA process for all new registrations - assessment for efficacy, safety and quality for its intended indications. Assessment took into account advice received from the TGA's Advisory Committee on Prescription Medicines and the Advisory Committee on the Safety of Medicines.
In keeping with publication of evaluation information on newly registered medicines, an Australian Product Assessment Report (AusPAR), which summarises the issues considered by TGA and any of its Committees in the decision to register the two medicines, will be made available within 30 days of the medicines being included on the ARTG.
Mifepristone is a synthetic steroid with an anti-progestational action. Misoprostol is a synthetic analogue of prostaglandin E1 and induces contractions of the smooth muscle fibres in the myometrium and relaxation of the uterine cervix. The combination of misoprostol, used in a sequential regimen after mifepristone, has been used for over 20 years in a number of countries for medical termination of pregnancy.
Both surgical and medical termination methods have risks and adverse effects associated with them, and decisions by a patient on the method of termination must be made in consultation with a medical practitioner.
The inclusion of the medicines on the ARTG is for the following approved indications:
- Mifepristone Linepharma 200 mg tablet is indicated in females of childbearing age for:
- Medical termination of a developing intra-uterine pregnancy, in sequential combination with a prostaglandin analogue up to 49 days of gestation.
- Preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.
- GyMiso® (misoprostol) is indicated in females of childbearing age for medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.
As with all market authorisation approvals, availability of the products will be managed by the sponsor - in this case, Marie Stopes International Australia.